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Ipsen demonstrates leadership position in neurotoxin research with strong presence at TOXINS 2019

Ipsen (Euronext: IPN; ADR: IPSEY) today announced that
abobotulinumtoxinA (Dysport®) and its recombinant botulinum
toxins pipeline are the subject of 50 posters at the 2019 TOXINS
International Conference. Results are presented from basic science (in
vivo, in vitro, ex vivo, in silico), to
clinical (Phase I to IV) and patients and caregivers surveys. Data
highlights include further differentiation of Dysport® in the
treatment of spasticity and movement disorders1, results from
the first in-human study of a recombinant neurotoxin (rBoNT-E), real
life data (ULIS-III) as well as a survey with insights from patients and
caregivers on the burden of spasticity (Carenity).

“Our data at TOXINS 2019 further differentiate Dysport®
in the treatment of spasticity and other movement disorders, and
demonstrate the headway we are making with our innovative pipeline,
including new recombinant botulinum toxins such as our fast-acting
rBoNT-E,” said Alexandre Lebeaut, Executive Vice President, R&D
and Chief Scientific Officer, Ipsen. “We look forward to many
more years of real and significant progress toward our commitment to
improving people’s lives through innovative and effective treatments and
by transforming the treatment paradigm with tailored approaches.”

With Dysport® (abobotulinumtoxinA), Ipsen offers a single
product to treat a range of therapeutic indications2.
Injected at approved doses, the amount of active neurotoxin in Dysport®
(data3 published in Toxins, in December 2018) may help to
explain the long-lasting symptomatic relief observed in clinical studies
(based on phase 3 trials4,5) within a well-characterized
safety and tolerability profile. With a long duration of response,
Dysport® aims at providing an answer to the unmet need of
patients and their families.

Alexandre Lebeaut added: “We are proud and excited to be
presenting these new data at TOXINS 2019 as we continue to build on more
than 30 years of clinical experience with Dysport®.
We will continue investing in this unique product through research and
novel programs studies to further explore its potential and address
patients’ unmet needs.”

About TOXINS conference

Held every 2 years, TOXINS is a key event for experts – clinicians and
researchers from academia and industry – in the field of neurotoxins and
especially Botulinum toxins. The international congress will take place
in 16-19 January 2019, in Copenhagen, Denmark. The TOXINS 2019
scientific program will feature presentations on the latest developments
in the basic science and clinical applications of neurotoxins.

About spasticity and cervical dystonia

Spasticity is a condition in which there is an abnormal increase in
muscle tone or stiffness in one or more muscles, which might interfere
with movement. Spasticity is usually caused by damage to nerve pathways
in the brain or spinal cord that control muscle movement, and may occur
in association with cerebral palsy, spinal cord injury, multiple
sclerosis, stroke, and brain or head trauma 8.

With a prevalence of 4.98/100,000 in Europe, cervical dystonia is the
most common adult-onset focal dystonia, a movement disorder
characterized by involuntary and sustained muscle spasms9.
Also known as spasmodic torticollis, cervical dystonia is an idiopathic
chronic condition in which the neck is twisted or deviated.

About Dysport®

Dysport® is an injectable form of a botulinum neurotoxin type
A product, which is a substance derived from Clostridium bacteria
producing BoNT-A that inhibits the effective transmission of nerve
impulses and thereby reduces muscular contractions6. It is
supplied as a lyophilized powder. As of 31 December 2018, Dysport®
had marketing authorization in more than 85 countries and more than 30
years of clinical experience7.

NOTE: Dysport® labels and approved indications may vary from
country to country

INDICATIONS AND IMPORTANT SAFETYINFORMATION

Dysport® is approved for the treatment of adult upper and
lower limb spasticity, paediatric lower limb spasticity and cervical
dystonia (referred to spasmodic torticollis in some markets) in many
international markets. Please refer to national labelling for details of
the locally approved prescribing information in each of these
indications.

Adverse effects resulting from the distribution of the effects of the
toxin to sites remote from the site of administration have been
reported. Patients treated with therapeutic doses may present with
excessive muscle weakness. The risk of occurrence of such undesirable
effects may be reduced by using the lowest effective dose possible and
by not exceeding the maximum recommended dose. Very rare cases of death,
occasionally in the context of dysphagia, pneumopathy (including but not
limited to dyspnoea, respiratory failure, respiratory arrest) and/or in
patients with significant asthenia have been reported following
treatment with botulinum toxin A or B. Patients with disorders resulting
in defective neuromuscular transmission, difficulty in swallowing or
breathing are more at risk of experiencing these effects. In these
patients, treatment must be administered under the control of a
specialist and only if the benefit of treatment outweighs the risk.
Dysport® should be administered with caution to patients with
pre-existing swallowing or breathing problems as these can worsen
following the distribution of the effect of toxin into the relevant
muscles. Aspiration has occurred in rare cases and is a risk when
treating patients who have a chronic respiratory disorder. Dysport®
should only be used with caution and under close medical supervision in
patients with clinical or sub-clinical evidence of marked defective
neuro-muscular transmission (e.g. myasthenia gravis). Such patients may
have an increased sensitivity to agents such as Dysport®,
which may result in excessive muscle weakness. Caution should be
exercised when treating adult patients, especially the elderly, with
focal spasticity affecting the lower limbs, who may be at increased risk
of fall. In placebo-controlled clinical studies where patients were
treated for lower limb spasticity, 6.3% and 3.7% of patients experienced
a fall in the Dysport® and placebo groups, respectively. The
recommended posology and frequency of administration for Dysport®
must not be exceeded. Patients and their care-givers must be warned of
the necessity to seek immediate medical treatment in case of problems
with swallowing, speech or respiratory problems. For the treatment of
spasticity in children, Dysport® should only be used in
children 2 years of age or over. As with any intramuscular injection,
Dysport® should only be used where strictly necessary in
patients with prolonged bleeding times, or infection/inflammation at the
proposed site(s) of injection. Dysport® should only be used
to treat a single patient, during a single session. Any unused product
remaining should be disposed of in accordance with Special Precautions
for Disposal and Handling. Specific precautions must be taken during the
preparation and administration of the product and the inactivation and
disposal of any unused reconstituted solution. This product contains a
small amount of human albumin. The risk of transmission of viral
infection cannot be excluded with absolute certainty following the use
of human blood or blood products.”

About Ipsen

Ipsen is a global biopharmaceutical group focused on innovation and
specialty care. The group develops and commercializes innovative
medicines in three key therapeutic areas – Oncology, Neuroscience and
Rare Diseases. Its commitment to Oncology is exemplified through its
growing portfolio of key therapies for prostate cancer, neuroendocrine
tumors, renal cell carcinoma and pancreatic cancer. Ipsen also has a
well-established Consumer Healthcare business. With total sales over
€1.9 billion in 2017, Ipsen sells more than 20 drugs in over 115
countries, with a direct commercial presence in more than 30 countries.
Ipsen’s R&D is focused on its innovative and differentiated
technological platforms located in the heart of the leading
biotechnological and life sciences hubs (Paris-Saclay, France; Oxford,
UK; Cambridge, US). The Group has about 5,400 employees worldwide. Ipsen
is listed in Paris (Euronext: IPN) and in the United States through a
Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For
more information on Ipsen, visit www.ipsen.com.

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